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SFDA issues Good Manufacturing Practice for Drug Excipients



The State Food and Drug Administration (SFDA) formulated and issued Good Manufacturing Practice for Drug Excipients after wide consultation, aiming to strengthen the quality control of the manufacturing of drug excipients and ensure drug excipient quality. Good Manufacturing Practice for Drug Excipients comprises eleven chapters: 
 
ChapterⅠ  General Provisions
ChapterⅡ  Organization, Personnel and Responsibility
ChapterⅢ  Buildings and Facilities
ChapterⅣ  Equipment
ChapterⅤ  Materials
ChapterⅥ  Sanitation
ChapterⅦ  Validation
ChapterⅧ  Documentation
ChapterⅨ  Production Control
ChapterⅩ  Quality Assurance and Quality Control
ChapterⅪ  Distribution
ChapterⅫ  Self-Inspection and Improvement
ChapterⅩⅢ Supplementary Provisions